NDAORALTABLET
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
NILANDRON (nilutamide) by ANI Pharmaceuticals is androgen receptor antagonists [moa]. First approved in 1996.
Drug data last refreshed 8h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NILANDRON (nilutamide) is an oral androgen receptor antagonist approved in 1996 for prostate cancer treatment. It works by blocking androgen receptors, inhibiting hormone-driven cancer cell proliferation. The drug is administered as a tablet and represents a first-generation hormone therapy in the androgen deprivation space.
$47KPart D
LOE ApproachingDeclining
<1% of prostate cancer market
Minimal commercial footprint with approaching loss of exclusivity signals a contracting team and limited growth opportunities.
Mechanism of Action
Androgen Receptor Antagonists
Pharmacologic Class:
Androgen Receptor Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer
Started May 2009
57 enrolled
Prostate Cancer
Career Relevance
NILANDRON offers minimal career advancement opportunity as a legacy, low-revenue product in steep competitive decline. Roles available are primarily maintenance-focused (regulatory, safety, legacy account management) with limited scope for strategic impact or professional growth.
Regulatory Affairs (compliance/lifecycle management)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.